OMEGA-3-POLYUNSATURATED FATTY-ACIDS (n3-PUFA) IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE: EFFECTS ON ENDOTHELIAL FUNCTION – A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND TRIA
- Conditions
- peripheral arterial disease (PAD) and intermittent claudication (IC)
- Registration Number
- EUCTR2009-018190-31-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik f.Innere Medizin II, Abt.f.Angiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Severity of disease: Rutherford category II or III – moderate to severe Stable intermittent claudication
Ankle Brachial Index<0.9
Age =18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Current treatment with Omacor or other fish oil products
Planned vascular intervention
Known hypersensitivity to the study drug
Rest pain or ischemic ulcer
Exercise tolerance limited by factors other than PAD
Unability to perform treadmill test
Dual antiplatelet therapy (aspirin and clopidogrel)
Previous myocardial infarction
Women of childbearing potential who do not practice a safe contraception method
Current participation in another intervention study.
Previous participation in another study with an intervention within the last 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method